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Gastric AdenocarcinomaMaGenNCT06902337

Gender Differences in Gastric Cancer Care and Its Adherence to Guidelines in Germany

An observational study of Gastric Adenocarcinoma, run by Medizinische Hochschule Brandenburg Theodor Fontane at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Gastric cancer is the fifth most common cancer globally and the fourth leading cause of cancer-related mortality. While gender differences in gastric cancer care are underexplored in Germany, international studies have revealed disparities in aspects such as histology, co-morbidities, treatment approaches… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Adenocarcinoma
How many people
75,000 participants
Where
1 siteGermany
Study dates
31 Jul 2025to 30 Jul 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: A) Cases from the DRG statistics for the years 2017-2021 with inclusion criteria minimum age 18 years, full inpatient hospital treatment in the years 2017-2021, ICD-10-GM code C16, C16.1 - C16.9 B) Cases recorded in a clinical cancer registry from 2017-2021 with ICD-10-GM code C16, C16.1-C16.9

Who may be able to join

  • Gastric adenocarcinoma ICD-10-GM code C16, C16.1 - C16.9

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • Medical School Brandenburg

    Brandenburg an der Havel, Brandenburg, 14770

Other trials in Germany

About this study

Official title: Gender Differences in Gastric Cancer Care and Its Adherence to Guidelines in Germany: A Observational Retrospective Cohort Study With Administrative Routine and Cancer Registry Data From 2017-2021

Background: Gastric cancer is the fifth most common cancer globally and the fourth leading cause of cancer-related mortality. While gender differences in gastric cancer care are underexplored in Germany, international studies have revealed disparities in aspects such as histology, co-morbidities, treatment approaches, and survival outcomes. This study aims to explore gender-specific variations in clinical management and their impact on mortality, complications, and survival rates in gastric carcinoma patients in Germany.

Methods: This nationwide, retrospective cohort study will analyze data from the German Diagnosis-Related Group statistic and regional clinical cancer registries from 2017 to 2021. The study will evaluate both datasets separately, providing a comprehensive view of gender differences in gastric cancer care. Primary outcomes include hospital mortality and survival rates, while secondary endpoints include surgical complications, treatment modalities, and postoperative outcomes. The analysis will investigate whether gender influences tumor characteristics, access to treatment, and therapy effectiveness. Statistical methods such as descriptive analysis, regression models, and survival analysis will be applied to identify gender-related variations in diagnosis, treatment, and outcomes.

Discussion: By identifying potential gender disparities in diagnosis, treatment, and outcomes, the findings may inform revisions to clinical guidelines and support the development of more personalized treatment strategies. This study aims to improve the quality of care for gastric cancer patients and promote more individualized, sex-sensitive medical practices.

Read the detailed description

Gastric cancer is the fifth most common cancer globally and the fourth leading cause of cancer-related mortality. While there is a lack of current data on gender differences in gastric cancer care in Germany, several international studies conducted on the basis of clinical cancer registry data have pointed to the relevance of this aspect in recent years. The analyses showed significant differences between women and men in aspects such as histology, co-morbidities, operations and therapies performed, and survival rates.

In Germany in 2017, 15,690 people were diagnosed with gastric cancer, of which 6190 were women (39%) and 9490 men (61%). The age-standardized rate of new cases is 7.8 for women and 14.9 for men. The risk of developing the disease increases with age in both sexes; men develop stomach cancer on average at the age of 71 and women at 76 years of age. There are regional differences between the federal states of Germany in all key figures. For example, in the state of Bavaria in 2019, both sexes have an above-average 5-year survival rate of 46.1% for men and 50.7% for women, while in the state of Brandenburg there is a large difference in this ratio between men (38.5%) and women (46.0%).

With regard to hospital mortality in Germany, an analysis of data from the DRG statistics for the years 2009 -2015 showed that the highest mortality rate of 11.7% was observed in patients undergoing visceral surgery in complex gastric surgery (in comparison, average hospital mortality among patients undergoing visceral surgery: 1.9%).

The aim of the project is to use routine data of the DRG statistic and data from the clinical cancer registries of the federal states to determine whether there are differences between women and men in the clinical care of gastric carcinomas and whether such different care has an impact on the mortality rate, complications and survival time of those affected.

Data from the hospital statistics (DRG statistics) and data from the clinical cancer registries are used as the data basis for the above-mentioned research questions and evaluated separately from each other.

In a first step, it will be investigated whether and to what extent women and men already differ in tumor characteristics (diagnosis, localization, histology, UICC stage, etc.) and in possible co-morbidities and co-variates such as age.

In a second step, the therapy (surgical procedures, oncological therapies) is analyzed under the focus variable gender. The aim here is to analyze whether women and men receive the same therapies if, for example, the tumor characteristics have the same tumor characteristics, or whether there are differences in both access and type of therapies.

In a third step, both the influence of the tumor characteristics and the therapies used on the outcome of the therapies will be investigated under gender-specific aspects. These include, for example, complications after surgery, side effects of oncological therapies, length of hospital stay, hospital mortality or long-term survival. It is of particular interest here whether there are particularly successful therapeutic strategies depending on gender and diagnosis with regard to the above-mentioned outcome parameters, i.e. whether there is a need to treat women and men differently if, for example, the tumor characteristics have the same tumor characteristics.

Since both analyses complement each other in their statements, the project can thus provide a comprehensive picture of gender-specific care in Germany. Furthermore, the project results provide a scientific data basis for a possible revision of the S3 guideline for the treatment of gastric cancer as well as for medical education and training.

Keywords
Gastric cancer, Sex differences, Clinicopathological characteristics, Treatment, Mortality, Survival, Treatment guidelines, Administrative routine data, Cancer registry data
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06902337
Study groupRoleWhat they receive
Patients with gastric adenocarcinomaGastric carcinoma (ICD-10-GM C16) Patients with gastric carcinoma in the years 2017-2021 in Germany, minimum age 18 years

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DRG statistic: in-hospital mortality

    Death in hospital after treatment in days

    Measured: 2017-2021

  2. Cancer registry: 1 and 3 year survival

    Survival after diagnosis date in months

    Measured: 2017-2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2025
  2. Study start31 Jul 2025
  3. Primary completion30 Jul 2026
  4. Study completion30 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
75,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06902337
Sponsor's protocol ID
MaGen (01VSF24051)
Other IDs
01VSF24051
Acronym
MaGen
Status last verified
Sep 2025
First submitted
21 Mar 2025
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to data protection

Publications

  • Weber U, Kress L, Hunger R, Schildberg C, Mantke R. Gender differences in gastric cancer care and its adherence to guidelines in Germany (MaGen): protocol for an observational retrospective cohort study with administrative routine and cancer registry data from 2017 to 2021. BMJ Open. 2026 Feb 2;16(2):e103467. doi: 10.1136/bmjopen-2025-103467.

    PubMed 41628928

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Adenocarcinoma, run by Medizinische Hochschule Brandenburg Theodor Fontane at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DRG statistic: in-hospital mortality (time frame: 2017-2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06902337, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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